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Philadelphia, PA PCI Pharma Services (“PCI”), a leading global contract development and manufacturing organization (CDMO) specializing in complex biopharma therapies, has announced a monumental investment exceeding $365 million. Operations at the first phase of the plant are scheduled to begin in Q3 2025.
AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinicaldevelopment of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia. Source link.
Cocrystal Pharma Receives FDA Guidance to Advance ClinicalDevelopment of its COVID-19 Antiviral CDI-45205 Cocrystal Pharma Receives FDA Guidance to Advance ClinicalDevelopment of its COVID-19 Antiviral CDI-45205 Response to pre-IND briefing package supports pathway to initiating a Phase 1 … Continue reading →
These molecules synthesised newly are packaged densely into custom lipid nanoparticles (LNPs), which Orna has made to act on the body’s crucial tissues. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments.
A 2020 PhRMA report on the cell and gene therapy pipeline found 362 therapies in a range of stages in clinicaldevelopment by biopharmaceutical companies in the United States. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA. Note: Some medicines are in more than one category.
Meeting Package Due. To address a stalled product development plan or an important safety issue. Sponsors whose products qualify for the centralized procedure can also seek scientific advice from the EMA anytime during development. All four types are free of charge to the sponsor, in contrast to EU meetings (discussed below).
They shared their extensive knowledge of the importance and implementation of diversity action plans in clinical trials. Dr. Oblak brings over a decade of experience in drug development, focusing on global clinicaldevelopment programs and the development of Diversity Action Plans.
Theoretically, at least, pharmaceutical companies should also be able to save money producing a single-dose FDC product, compared to what it would cost to manufacture, package, and market two or three individual drugs. Accelerated regulatory pathway. Working with a CDMO partner.
Cholesgen (Shanghai) has announced a three-year partnership with AstraZeneca to advance research and development (R&D) in hypercholesterolemia and related metabolic diseases. The companies will validate genetic drug targets and advance therapeutic molecules into clinicaldevelopment.
Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinicaldevelopment that have key implications for entering markets successfully.
Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinicaldevelopment. CluePoints provides clinical studies with risk management support package during Covid-19.
But now it’s a warning in their package insert. Well, the first obstacle was that the pharmaceutical industry does not want to develop drugs for children. In the Pediatric Study Plan, you have a defined timeline and a defined plan, a clinicaldevelopment plan that has to be approved by the FDA.
In many cases, pharma companies select a contract development and manufacturing organisation (CDMO) to develop products versus doing the work themselves for reasons related to cost, convenience, and capacity. Waiting in a long queue of higher priority large-scale manufacturing runs makes for lengthy and uncertain delivery timelines.
The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.
Going forward, F2G is continuing clinicaldevelopment for Olorofim alongside partners Shionogi & Co, who have commercial responsibility for the drug in Europe and Asia Pacific. It plans to work with the FDA to plan new analyses and further develop a new application package.
Now, after discussions with the FDA, the two companies have said they are confident that the current data package is strong enough to move forward with filings in MDD in the second half of 2022, and in postpartum depression (PPD) the following year.
Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinicaldevelopment and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.
Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinicaldevelopment programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Food & Drug Administration.
In addition, clinical biomarker data confirm proof of mechanism in patients. “The solid clinicalpackage from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. and AC101 in clinicaldevelopment by Shanghai Henlius Biotech Inc.).
Jeff Vassallo, Senior Director of Clinical Trial Management, at the global clinical contract research organization (CRO) Medpace. These details must be thoughtfully considered early in clinicaldevelopment to ensure studies are completed within the projected timeline and budget,” added Dr. Vassallo.
Metrion Biosciences’ ion channel expertise includes an industry leading panel of in vitro cardiac ion channel safety assays, translational native cell and phenotypic assays for neurological and cardiotoxicity testing, and a range of other ion channel screening services such as cell line development and optimization.
Now poised to advance a robust therapeutics pipeline to clinicaldevelopment, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.
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MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.
A: If the GCLP term referenced is interpreted as a combination of good laboratory practice (GLP) and good clinical practice (GCP), then the roadmap needs to include processes covering pre-clinical and clinicaldevelopment stages.
Lilly intends to submit the full registration package to regulatory authorities by the end of 2021. The SURPASS phase 3 global clinicaldevelopment program for tirzepatide has enrolled more than 19,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies.
The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than five transfer RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).
These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)
Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration (..)
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” “The investigational cocktail is now available to indicated high-risk U.S.
Lilly intends to submit the full registration package to regulatory authorities by the end of 2021. The SURPASS phase 3 global clinicaldevelopment program for tirzepatide has enrolled more than 19,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies. mg, 5 mg and 7.5
REGN5458 and odronextamab are currently under clinicaldevelopment, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.
CMC Development and Readiness Pilot (CDRP) and Support for Accelerated Development Programs – Acknowledging that drug development programs eligible for accelerated clinicaldevelopment (i.e. Notable Dates and Timelines – Applications open, Q4 of FY 2023.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,
Yet, we reached that pre-specified number of responses, which is a good sign for us to expand the clinicaldevelopment then and treat more patients, so we have a larger database.”. It’s clearly the moment today to develop drugs that can improve that deliverable.”. Only 50% of the patients were recruited.
Most of the cell therapies in clinicaldevelopment today are of autologous origin. However, we have seen a significant increase in the number of allogeneic agents in phase I and phase II development. Unique logistics considerations. Building a robust cryogenic storage and logistics platform.
“We are pleased to offer two potential new treatment options with KEYTRUDA for patients in Japan based on compelling data from our clinical trial program,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories. months (95% CI, 7.6-11.3)
“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. . “We appreciate the continued support of patients and investigators around the world who are working to advance Regeneron’s antibody cocktail trials under very challenging circumstances,” said David Weinreich , M.D.,
Key Pipeline Progress Regeneron has more than 20 product candidates in clinicaldevelopment, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Non-GAAP net income per share – diluted (1). $. Business Highlights.
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.
At its Investor Update, GSK announced a package of new financial outlooks and ambitions. This business has benefited from operational integration with pharmaceuticals in key areas for many years, notably commercial operations and clinicaldevelopment; but is also operationally independent where it is optimal, for example in manufacturing.
The oRNAs can also be packaged into lipid nanoparticles, which can help with delivery and potentially can allow them to be targeted to specific tissues in the body. ” It added that the alliance will draw on its expertise in “nucleic acid biology, clinicaldevelopment, and manufacturing.”
The filing of an IND will enable participation of US medical centers in future clinical studies of Rabeximod in Covid-19, rheumatoid arthritis and potential other indications. The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies.
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